Bill Sardithe vitamin supplement answer man

It’s the middle of summer on a holiday weekend, late on Friday afternoon, and the American public is readying themselves for another 4th of July celebration. It’s the typical point in time, when the populace is distracted, that government agencies often pick to release a bombshell that won’t likely be popular with the public. And it was some bombshell.

The Food & Drug Administration (FDA) had secretively, albeit belatedly, drafted a 47-page guideline pointed at dietary supplement companies, with a demand they prove their newly introduced products are safe. It was written without input from industry. The rub is that the guideline extends back 16 years to any new dietary ingredient introduced after the Dietary Supplement Health & Education Act (DSHEA) was passed in 1994. This includes popular dietary supplements such as resveratrol curcumin, hyaluronic acid, acai berry, and many others. Thousands of new dietary ingredients have been introduced over that time, and only a few hundred of them actually had safety data filed with the FDA. Shame, shame.

Where are the dead bodies and the maimed babies?

Yet, during the decade-and-a-half long time gap in implementing this safety provision in the DSHEA, no birth defects were reported for newly introduced dietary supplements like there were for drugs such as diethylstilbestrol and thalidomide. With a couple of exceptions (discussed below), there were no deaths or significant side reactions attributed to dietary supplements over this same time period. New dietary ingredients had entered the marketplace for what was to be the largest uncontrolled human experiment. There would be no placebos, no eliminating criteria (stacking the deck) as with controlled studies. The young, old, infirm and sturdy partook of dietary supplements in presumed faith they were relatively safe. They weren’t wrong in their choice.

Over this same time American Poison Control Centers tabulated deaths and side reactions caused by vitamin, mineral and herbal products, and there was nary a death attributed to these self-prescribed remedies.

Herbal weight loss supplement unfairly banned

Oh, the weight-loss stimulant Ephedra (Ma Huang) was banned due to a few associated deaths, but those were largely attributed to overdosing on this herbal-based molecule. Oddly, the FDA continued to allow a synthetic version, pseudoephedrine, to be marketed in various over-the-counter cold and cough remedies, even though it exhibited similar biological activity.

One can overdose on aspirin, no problem. Aspirin in standard doses kills an estimated 6000 Americans every year, largely due to bleeding gastric ulcers, but remains on store shelves. It’s those dratted dietary supplements like Ephedra that have to be weeded away.

Ephedra was the only effective product to produce lean body mass in an era of growing obesity in America, and it was yanked off the shelves via irresponsible overuse by crash dieters whose families were looking to sue. The news media publicized the deaths to create public doubt over the safety of all dietary supplements. There were cries for more regulation at the time.

The tryptophan fiasco

Then there was tryptophan, an amino acid supplement that was rapidly replacing various antidepressant drugs and sleeping pills. It was found to be a better antidepressant than placebo pills, which cannot be said for most of antidepressant drugs.

Oddly, the US Food & Drugged Administration chose to ban all tryptophan supplements regardless of their origin. After all, America was about to enter the Prozac era of psychopharmacology. This was a tip off that the whole tryptophan fiasco was orchestrated to protect sales of prescription pharmaceuticals, which appears to be a hidden agenda at the FDA.

FDA approved?

The problem is that during this time period many FDA-approved drugs had been recalled after they had entered into broad use and were found to be ineffective, or even worse, result in premature death. This included big-name drugs like Meridia, Bextra, Vioxx, and others. A long list of FDA-approved drugs that were eventually withdrawn from the market place can be viewed here.

License to kill

For comparison, the dietary supplement industry doesn’t have such leeway. If a few people are harmed or die from supplements, news headlines blare across the front page of newspapers as well as on network TV news. Network evening TV news programs are largely sponsored by pharmaceutical advertising, so don’t anticipate a fair hearing for dietary supplements from the news media.

In effect, there is a distorted drug safety review process where attainment of FDA approval is essentially a license to kill. If there were no FDA and these products had to stand naked to public scrutiny and legal liability without the imprimatur of a government agency, the private legal system would pounce upon these drugs in rapid manner and eliminate them via a flood of liability suits.

Slanted news reports

This writer tracked the way the news media spun the FDA announcement of new safety reporting guidelines for dietary supplements.

Susan Brady, a HealthNews.com reporter said: “rigorous testing providing safety and effectiveness data, which is required of all drugs, is not conducted in the same way for dietary supplements. And therein lies the problem.”

But just how did dietary supplements, without pre-market safety reporting guidelines, not only end up being safer than FDA-approved prescription drugs, but also comparatively safer than aspirin, tap water, table salt and even food itself?

HealthNews.com reporter Brady penned her report with the headline “FDA Attempting To Regulate Dietary Supplements,” as if a begrudging supplement industry was dragging its feet over the issue. Yet it was the FDA itself that was 16-years late in drafting the safety guidelines for new dietary ingredients. Was the FDA hoping another thalidomide-like flurry of birth defects would doom the dietary supplement industry?

Such a news report as Brady’s, which essentially posed the unstated question of “why don’t you want to be regulated?,” was like asking a man “when was the last time you beat your wife?” Any answer to that type of baited question would be defensive and self-incriminating and would not be allowed in a court of law. But there is no judge in the court of public opinion.. The dietary supplement industry is going to sound half-guilty any way it responds.

But that made it sound like supplement companies were remiss in filing. Without written guidelines in place, supplement companies were left to guess what the FDA wanted and many New Dietary Ingredient (NDI) applications were rejected. It also made it sound like the supplement industry has no objection to the FDA guideline itself, when it is a doomsday document for many small and large companies.

The newly released guidelines spell out a long list of safety tests that may take years to complete at great expense. Some companies may be able to skirt around costly toxicity and birth defect studies if they can show years of safe use, but the FDA is talking about no less than 25 years of safe use.

The FDA surely must know that the cost of complying with the new guidelines is beyond the capability of many small companies, and larger supplement companies which offer hundreds of items on store shelves will have to spend millions to prove their products are safe on paper despite the fact they have been in common use for years without reported problems.

A spokesperson for an association of retail store owners and manufacturers in the supplement industry said her group “plans to ask the FDA to ease up on some guidelines,” again making it sound like the supplement industry wants to water-down safety requirements.

With an ear to the ground, this writer hears the public talking about a black market if popular dietary supplements are eventually pulled from store shelves. But the FDA is one step ahead of this anticipated public response.

Within days of the FDA announcement over guidelines for new dietary supplement ingredients, the FDA also issued an anti-smuggling strategy. An FDA press release says: “The FDA issued an anti-smuggling strategy developed by the Department of Health and Human Services (HHS) in coordination with the Department of Homeland Security (DHS) that will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.”

It appears the FDA knew that talk of a black market would arise and they took pre-emptive action by involving a more formidable policing agency – the Department of Homeland Security.

Supplement industry is clueless

Most of the involved parties in the dietary supplement industry still don’t know what hit them. Some believe they will dutifully comply with newly penned FDA guidelines, not recognizing this document will doom a growing industry in a dying economy.

The future of pharmacology

The dietary supplement industry holds the greatest promise for reducing the high cost of medical care. Once existing drug patents expire and newly introduced synthetic molecules are no better than older generic drugs, the pharmaceutical industry may attempt to turn so-called nutriceuticals into prescription drugs as they are in Europe.

Americans enjoy the freedom to purchase, at least for now, natural remedies without a doctor’s prescription and at far less cost than in other countries. For example, herbal remedies such as bilberry and Ginkgo biloba are prescription-only remedies throughout Europe.

Big Pharma is closing in on a big power grab – and it must to save itself. That is because modern designed drugs represent a single man-made (patentable) molecule that narrowly targets single genes or cell receptor sites in an attempt to quell symptoms of a sole disease. Whereas, by definition, nutriceuticals are single natural molecules that target hundreds of genes and therefore prevent, treat or cure many diseases.

Modern pharmacology must counter this threat from natural medicine if it is to survive. It must capture nutriceuticals and make them prescription-only substances. It must demonize dietary supplements in the short run and convince the American public they are potentially hazardous and need to be controlled by prescription.

Dietary supplements are not a trivial issue in America. The most letters sent to Congress over any issue in the past two decades involved the public’s support for the passage of the Dietary Supplement Health & Education Act of 1994. It has been said that there are three issues politicians dare not tamper with in America: the right to bear arms, the privacy of the American home, and the right to directly purchase dietary supplements unfettered by government.

Many Europeans travel to America to purchase a year’s supply of dietary supplements that are far more expensive in their native country. These foreign consumers come to America because this is a land known for free markets and freedom to use dietary supplements. It would be an embarrassing irony, in “the land of the free,” that under the guise of consumer protection, health freedom and the right to self-care would be discarded.

One Response to “Dietary Supplements Face Overkill While FDA-Approved Drugs Have A License To Kill”

Wayne Says: July 19th, 2011 at 10:39 am

Mr. Sardi,

I see your comments on Nutra Ingredients articles. Lately, regarding NDI, I see a major scam being played out. For example, Orrin hatch of Utah is firmly embedded in this issue. We both know that Utah is loaded with supp. manufacturers, many well-financed, who would love less competition. However, Orrin hatch recently began stumping for “tax deductible” supplements under Obama’s health care bill.

Under this “scam”, the Feds would endorse supplements as “preventative medicine”…NEVER done before. Also, supplements will most likely be doled out by insurance companies, or at least through “preferred contractors”. In essence, this will create government contract opportunities for the large companies remaining after NDI eliminates 90% of manufacturers.

Orrin hatch has no doubt been allowing the companies “contributing” to his retirement fund and future private sector board member seat, to write the NDI bill. This, to me, is stinking like a fish on a hot sidewalk. My question for you is this:

WHAT CAN WE DO to expose this corruption? I have a Dutch friend here in the US who’s involved in the health insurance business. He told me that insurance companies will be doling out everything from whey protein powder to echinacea.

This is not an inconvenience, this is corruption. Can we start a campaign of exposure? We all have influential people in our networks, perhaps we can reach as high as possible to expose this scam. Let’s reach as high as Ron Paul.. he is an advocate of the freedom they are stealing. You write for Lew Rockwell, perhaps we can get it some front and center attention.

I will do what I can with the network I have, but we need to mobilize to defeat this..

Thank you for your time..

Wayne Kilbourn

KnowledgeOfHealth.com:

I will be launching a major offensive against New Dietary Ingredient guidelines and inviting others to join in confronting Congressional leaders against this tyranny from the FDA. More to follow. What you mention here is the prospect that dietary supplements would be tax deductible at some point in time. That wouldn’t really apply to many people since they submit standard tax filings with no deductions. Haven’t read the proposal yet. Don’t know how that would prompt insurance companies to sell dietary supplements. One would think insurance companies would embrace preventive medicine, but in fact, the insurance companies also want to run up the bill. Insurance companies maybe net 2% of the money that filters through their hands. So the larger the bill, the more they profit. Insurance companies also make a large amount of money by delaying payments and using money intended for patient care to make investments. Any day health insurance companies could embrace preventive medicine, but they don’t. In fact, what you see is insurance companies sending out nurses to do home health check ups and take blood samples that literally force a person to take statin cholesterol-lowering drugs or they will have their insurance policy canceled. This is coercive or fascist medicine. – Bill Sardi